A common method of health care therapy is infusion or intravenous (“I.V.”) therapy, whereby fluids possessing desired medication or other characteristics are infused into a patient over varying lengths of time. I.V. therapy generally requires a source container of a fluid, an administration set and a catheter. This method of infusion therapy requires that a connection be made between these components for the transfer of fluid, along a fluid passageway, from a fluid source to a patient.
In addition, infusion therapy frequently requires one of the solutions, which is to be administered to be formulated in the source container according to a certain prescription intended to provide benefit to the patient. Frequently this prescription is compounded by injecting medicaments into a container, which is partially filled with a diluent. Most of these containers presently include a medication port and an administration port. The medication port includes a solid rubber septum, which is penetrated by a needle attached to the end of a syringe, which contains the medicament, and the medicament is then injected through the septum into the diluent. Frequently multiple medicaments are injected into such a container.
Many medicaments pose a hazard to health care workers. Cytotoxic drugs used for chemotherapy pose a significant effect to workers due to their highly toxic properties. Moreover, using needles to puncture the septum in the medicament port poses a needle-stick hazard, which is only compounded by the presence of highly toxic fluids.
One widely used connector for establishing a connection between the administration set and a catheter and to provide a fluid passageway is a luer connection assembly in which mating male and female components are releasably joined. In addition, syringes are generally manufactured with a male luer connector onto which the female luer needle is attached. The luer connector has a blunt tip, which does not pose a health hazard.
Recently, devices for establishing a luer connection to a vial containing lypholized drugs have been used. These connectors eliminate the need for the health care worker to penetrate the stopper of the drug vial with a needle in constituting and withdrawing the medicament. However, if the resulting liquid medicament must be injected into a medication port, the worker must then affix a needle to the syringe luer tip thus presenting the needle hazard.
However, use of a medication port having a solid rubber septum provides many desirable benefits. Use of the solid septum has been shown to prevent the microbial ingress even when the container is subjected to terminal sterilization of the container by high pressure steam or handling during distribution and use. In addition, the smooth outer surface allows the health care worker to easily wipe the septum prior to connection, thus promoting sterility.
However, a solid rubber septum cannot be penetrated by a luer tip. In addition, there are other needle-free connection systems such as a blunt cannula and slit septum system which does not pose a needle-stick hazard but such a blunt cannula cannot penetrate a solid rubber septum. In addition, there is also a risk of drug spillage when the administration port is accessed by a spike of an administration set being used to administer a drug to the patient.
Thus, it is an object of the present invention to provide a method and device for allowing needle-free access to the medicament port of a container and to use this device for the administration of a solution. A more particular object is to provide such a method and device which allows multiple needle-free accesses to the medicament port of a container.
Another object of the present invention is to provide a method and device which allows access to the medicament port of the container without exposing the health care worker to a needle-stick hazard. A more particular object of the present invention is to provide a method and device to allow a luer tip or blunt cannula to access the medicament port of the present container.
A still further object of the present invention is to provide a device meeting the above discussed objects while still preserving the benefits supplied by a solid elastomeric septum, including the benefit that the sterile passageway through the lumen and the luer fittings prior to use is sealed against microbial ingress during use.